55470 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices 

principles of and the kind of data 

needed for PBPK modeling, and 

discusses some approaches for the 

evaluation and use of PBPK models in 

the health assessment of environmental 

agents. PBPK models represent an 

important class of dosimetry models 

that are useful for predicting internal 

doses to target organs. To predict 

internal dose level, PBPK models use 

physiological, biochemical, and 

physicochemical data to construct 

mathematical representations of 

processes associated with the 

absorption, distribution, metabolism, 

and elimination of compounds. With 

the appropriate data, these models can 

be used to extrapolate across species 

and exposure scenarios, and address 

various sources of uncertainty in health 

assessments. 

This report addresses the following 

questions: (1) Why do risk assessors 

need PBPK models; (2) How can these 

models be used in risk assessments; and 

(3) What are the considerations for 

evaluating whether a PBPK model can 

be used in a given health assessment of 

an environmental agent? 

The report is not intended to be used 

as Agency guidance on the use of PBPK 

modeling and does not specify when to 

use a PBPK model in health assessments 

of environmental agents. 

Dated: September 14, 2006. 

George W. Alapas, 

Acting Director, National Center for 

Environmental Assessment. 

[FR Doc. 06–8053 Filed 9–21–06; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[FRL–8221–8; Docket ID No. EPA–HQ–ORD–

2006–0756] 

Evaluation of the Carcinogenicity of 

Ethylene Oxide 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice of public comment 

period. 

SUMMARY: EPA is announcing a 30-day 

public comment period for the draft 

document titled, ‘‘Evaluation of the 

Carcinogenicity of Ethylene Oxide’’

(EPA/635/R–06/003). The document 

was prepared by the National Center for 

Environmental Assessment within 

EPA’s Office of Research and 

Development. 

EPA is releasing this draft document 

solely for the purpose of seeking public 

comment and for review by the EPA 

Science Advisory Board (SAB) via a 

meeting to be held later in 2006 (time 

and place to be specified in a separate 

Federal Register notice). This document 

has not been formally disseminated by 

EPA. It does not represent and should 

not be construed to represent any 

Agency policy or determination. EPA 

will consider any public comments 

submitted in accordance with this 

notice when revising the document. 

DATES: The 30-day public comment 

period begins September 22, 2006, and 

ends October 23, 2006. Technical 

comments should be in writing and 

must be received by EPA by October 23, 

2006. 

ADDRESSES: The draft ‘‘Evaluation of the 

Carcinogenicity of Ethylene Oxide’’ is 

available primarily via the Internet on 

the National Center for Environmental 

Assessment’s home page under the 

Recent Additions and the Data and 

Publications menus at http:// 

www.epa.gov/ncea. A limited number of 

paper copies are available from the 

Technical Information Staff, NCEA–W; 

telephone: 202–564–3261; facsimile: 

202–565–0050. If you are requesting a 

paper copy, please provide your name, 

your mailing address, and the document 

title, ‘‘Evaluation of the Carcinogenicity 

of Ethylene Oxide.’’ Please provide your 

name, your mailing address, the title, 

and the EPA number of the requested 

publication. 

Comments may be submitted 

electronically via www.regulations.gov, 

by mail, by facsimile, or by hand 

delivery/courier. Please follow the 

detailed instructions provided in the 

SUPPLEMENTARY INFORMATION section of 

this notice. 

FOR FURTHER INFORMATION CONTACT: For 

information on the public comment 

period, contact the Office of 

Environmental Information Docket; 

telephone: 202–566–1752; facsimile: 

202–566–1753; or e-mail: 

ORD.Docket@epa.gov. 

For technical information, contact 

Henry D. Kahn, D.Sc., NCEA; telephone: 

202–564–3269; facsimile: 202–565–

0079; or e-mail: kahn.henry@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Information About the Project/ 

Document 

Ethylene oxide (EtO) is a gas at room 

temperature. It is manufactured from 

ethylene and used primarily as a 

chemical intermediate in the 

manufacture of ethylene glycol. It is also 

used as a sterilizing agent for medical 

equipment and as a fumigating agent for 

spices. The largest sources of human 

exposure are in occupations involving 

contact with the gas in production 

facilities and in hospitals that sterilize 

medical equipment. EtO can also be 

inhaled by residents living near 

production or sterilizing/fumigating 

facilities. 

This draft assessment document 

characterizes the potential for a 

carcinogenic health hazard from human 

inhalation exposure to EtO. This is 

accomplished by a weight-of-evidence 

evaluation as to how likely EtO is to be 

a human carcinogen, as well as an 

evaluation of related dose-response 

information which leads to the 

development of lifetime cancer risk 

estimates per unit of exposure. This 

assessment, when finalized, will be 

posted to EPA’s Integrated Risk 

Information System (IRIS) database. The 

document was prepared by EPA’s 

National Center for Environmental 

Assessment (NCEA). EPA last published 

a health assessment of the potential 

carcinogenicity of EtO in 1985 (U.S. 

EPA, 1985). 

The current assessment reviews the 

more recently developed database on 

the carcinogenicity of EtO, pertinent 

data from the 1985 assessment, and 

several reviews and assessments issued 

by other organizations (IARC, 1994; 

Health Canada, 2001; CalEPA, 1999; 

EOIC, 2001). 

II. How To Submit Technical Comments 

to the Docket at www.regulations.gov 

Submit your comments, identified by 

Docket ID No. EPA–HQ–ORD 2006–

0756 by one of the following methods: 

• www.regulations.gov: Follow the 

on-line instructions for submitting 

comments. 

• E-mail: ORD.Docket@epa.gov. 

• Fax: 202–566–1753 

• Mail: Office of Environmental 

Information (OEI) Docket (Mail Code: 

2822T), U.S. Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460. The phone 

number is 202–566–1752. 

• Hand Delivery: The OEI Docket is 

located in the EPA Headquarters Docket 

Center, EPA West Building, Room B102, 

1301 Constitution Ave., NW., 

Washington, DC. The EPA Docket 

Center Public Reading Room is open 

from 8:30 a.m. to 4:30 p.m., Monday 

through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is 202–566–1744. 

Such deliveries are only accepted 

during the docket’s normal hours of 

operation, and special arrangements 

should be made for deliveries of boxed 

information. 

If you submit comments by mail or 

hand delivery, please submit one 

unbound original with pages numbered 

consecutively, and three copies of the 

comments. For attachments, provide an 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices 55471 

index, number pages consecutively with 

the comments, and submit an unbound 

original and three copies. 

Instructions: Direct your comments to 

Docket ID No. EPA–HQ–ORD–2006–

0756. Please ensure that your comments 

are submitted within the specified 

comment period. Comments received 

after the closing date will be marked 

‘‘late,’’ and may only be considered if 

time permits. It is EPA’s policy to 

include all comments it receives in the 

public docket without change and to 

make the comments available online at 

www.regulations.gov, including any 

personal information provided, unless a 

comment includes information claimed 

to be Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. Do 

not submit information that you 

consider to be CBI or otherwise 

protected through www.regulations.gov 

or e-mail. The www.regulations.gov Web 

site is an ‘‘anonymous access’’ system, 

which means EPA will not know your 

identity or contact information unless 

you provide it in the body of your 

comment. If you send an e-mail 

comment directly to EPA without going 

through www.regulations.gov, your email address will be automatically 

captured and included as part of the 

comment that is placed in the public 

docket and made available on the 

Internet. If you submit an electronic 

comment, EPA recommends that you 

include your name and other contact 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. For additional information 

about EPA’s public docket visit the EPA 

Docket Center homepage at 

www.epa.gov/epahome/dockets.htm. 

Docket: Documents in the docket are 

listed in the www.regulations.gov index. 

Although listed in the index, some 

information is not publicly available, 

e.g., CBI or other information whose 

disclosure is restricted by statute. 

Certain other materials, such as 

copyrighted material, are publicly 

available only in hard copy. Publicly 

available docket materials are available 

either electronically in 

www.regulations.gov or in hard copy at 

the OEI Docket in the EPA Headquarters 

Docket Center. 

Dated: September 15, 2006. 

George W. Alapas, 

Acting Director, National Center for 

Environmental Assessment. 

[FR Doc. 06–8054 Filed 9–21–06; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2006–0351; FRL–8076–3] 

Pesticides; Draft Guidance for 

Pesticide Registrants on Use of 

Antimicrobial Pesticide Products in 

Heating, Ventilation, Air Conditioning, 

and Refrigeration Systems 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice of availability. 

SUMMARY: The Agency is announcing 

the availability of and seeking public 

comment on a draft Pesticide 

Registration Notice (PR Notice) entitled 

‘‘Use of Antimicrobial Pesticide 

Products in Heating, Ventilation, Air 

Conditioning and Refrigeration 

Systems.’’ PR Notices are issued by the 

Office of Pesticide Programs (OPP) to 

inform pesticide registrants and other 

interested persons about important 

policies, procedures, and registration 

related decisions, and serve to provide 

guidance to pesticide registrants and 

OPP personnel. This particular draft PR 

Notice would, once final, provide 

guidance to the registrants concerning 

EPA-registered sanitizer, disinfectant 

and other antimicrobial products whose 

labels bear general directions for use on 

or incorporation within hard, nonporous or porous surfaces, but which 

are not specifically registered for 

treatment of Heating, Ventilation, Air 

Conditioning and Refrigeration Systems 

(HVAC&R). 

DATES: Comments must be received on 

or before November 21, 2006. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2006–0351, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Building), 2777 S. 

Crystal Drive, Arlington, VA. Deliveries 

are only accepted during the Docket’s 

normal hours of operation (8:30 a.m. to 

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket telephone number is (703) 305–

5805. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPP–2006–

0351. EPA’s policy is that all comments 

received will be included in the docket 

without change and may be made 

available on-line at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov or email. The Federal regulations.gov 

website is an ‘‘anonymous access’’

system, which means EPA will not 

know your identity or contact 

information unless you provide it in the 

body of your comment. If you send an 

e-mail comment directly to EPA without 

going through regulations.gov, your email address will be automatically 

captured and included as part of the 

comment that is placed in the docket 

and made available on the Internet. If 

you submit an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD-ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. 

Docket: All documents in the docket 

are listed in the docket index. Although 

listed in the index, some information is 

not publicly available, e.g., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either in the 

electronic docket at http:// 

www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S–

4400, One Potomac Yard (South 

Building), 2777 S. Crystal Drive, 

Arlington, VA. The hours of operation 

of this Docket Facility are from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

telephone number is (703) 305–5805. 


sroberts on PROD1PC70 with NOTICES